Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) reported second-quarter 2026 net product revenue of approximately $13.5 million, a substantial increase from $2 million in the year-ago period. The growth was driven by approximately $11 million in net sales of TONMYA, the company's recently approved treatment for fibromyalgia. During the quarter, TONMYA recorded 12,592 total prescriptions, a 100% sequential increase, with new patient prescriptions up 36% and refills rising 207%.
The company also provided updates on its commercial and clinical progress. TONMYA currently has coverage representing approximately 136 million lives across commercial, managed Medicare, and Medicaid channels. Coverage is expected to expand to approximately 145 million lives when a managed Medicare agreement takes effect on January 1, 2027. This broadening access is crucial for the drug's adoption among fibromyalgia patients, a condition for which TONMYA is the first new treatment in over 15 years.
Tonix is also advancing its pipeline beyond TONMYA. The company has enrolled the first patient in the potentially pivotal Phase 2 HORIZON study evaluating TNX-102 SL for major depressive disorder (MDD). This study aims to assess the drug's efficacy in a new indication, potentially expanding its therapeutic utility. Additionally, Tonix is preparing to begin an adaptive Phase 2 field study of TNX-4800 for Lyme disease prevention in the first quarter of 2027, pending final FDA review and agreement on the protocol.
The company ended the quarter with approximately $176.2 million in cash and cash equivalents. According to Tonix, these resources, together with third-quarter equity proceeds to date, are expected to fund planned operations and capital expenditures into early second-quarter 2027. This financial position provides a runway to support ongoing commercial efforts and clinical development.
The positive financial results and pipeline advancements underscore Tonix's transition from a development-stage company to a fully integrated commercial-stage biotechnology firm. The robust sales growth of TONMYA reflects strong market demand and successful launch execution. With an expanding patient access and a promising pipeline, Tonix is positioning itself to address high unmet medical needs in central nervous system (CNS) and immunology.
For more information, visit the company's newsroom at https://nnw.fm/TNXP.
Tonix Pharmaceuticals is a fully integrated, commercial-stage biotechnology company focused on CNS and immunology treatments in areas of high unmet medical need. TONMYA (cyclobenzaprine HCl sublingual tablets 2.8mg) is the company's flagship medicine. The company's CNS commercial infrastructure also supports its acute migraine products, Zembrace SymTouch and Tosymra. Tonix is maximizing the science behind TONMYA in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder. In addition, the CNS portfolio includes TNX-2900, which is Phase 2 ready for the treatment of Prader-Willi syndrome, a rare disease. The company is also advancing a pipeline of immunology programs, including monoclonal antibody TNX-4800 for Lyme disease prophylaxis and TNX-1500, a third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection.
